Medical sterile containers, also referred to as sterilization containers or sterile containers, are used, in particular, by surgeons and their assistants to sterilize and store surgical instruments and implants in a simple way. For this purpose, the articles to be sterilized, after thorough cleaning, are first placed in the container interior. After closure, the sterile container is sterilized in a sterilization apparatus, also referred to as sterilizer or autoclave, together with its contents. In order that sterilization of the contents of the sterile container is possible at all in the closed state, the latter usually comprises gas exchange openings which allow saturated steam to enter the container interior to sterilize the container contents. The gas exchange openings may be permanently open for gas exchange. In this case, they are then completely closed by a sterile barrier, for example, a filter, but the sterile barrier allows gas exchange. Alternatively, gas exchange openings may also be closed by valves, which only open when the sterile container is located in the sterilization apparatus and is undergoing a sterilization process, in order to allow saturated steam to flow into the container and, possibly, moisture to exit from it again, and automatically close the gas exchange openings again after completion of the process.
In a sterilization process, the sterile container undergoes hot steam treatment in a sterilization apparatus, during which it is subjected to saturated steam at a temperature of typically 134° and a pressure of approximately 3.1 bar for a prescribed duration of between 3 and 60 minutes.
After it has undergone the complete sterilization process in the sterilization apparatus, the sterilization status “sterile” can be allocated to the sterile container, i.e., its interior and the articles contained therein.
In sterile containers available on the market, it is known to automatically set the sterilization status to “sterile” and indicate in a corresponding manner when a limit temperature is exceeded during the sterilization process. For example, optical indicators are known, which, after a temperature of, for example, 115° is exceeded, change their color and, therefore, indicate to a user that the sterile container has allegedly undergone a sterilization cycle.
A disadvantage of such systems is, however, that they only react to temperature changes. In other words, the sterilization status “sterile” would also be allocated to a sterile container if the prescribed temperature had been exceeded, but no saturated steam had flowed into the container for sterilization of the articles contained in the container.
Since the validation of the sterilization process is extremely important, in particular, in hospitals, all kinds of indicators of the sterilization status which allocate the sterilization status “sterile” to a sterile container when there is no clear guarantee that this sterilization status actually exists are unacceptable. Consequently, temperature-activated sterilization status detection is unsuitable for establishing with absolute certainty that the sterile container and its contents have undergone a sterilization process properly.
Therefore, it would be desirable to provide a medical sterile container and a method for determining the sterilization status of a medical sterile container which allow reliably allocating the sterilization status “sterile”.